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Start Preamble

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

EPA is currently engaged in a comprehensive reassessment of the time-limited registrations for all existing Bacillus thuringiensis (B.t.) corn and cotton plant-pesticides. This reassessment has been designed to assure that the decisions on the renewal of these registrations are based on the most current health and ecological data (including recently reviewed non-target impact data), and incorporates recommendations made by the FIFRA Scientific Advisory Panel (SAP). The reassessment process has also been designed to assure maximum transparency of the decision making process. In addition to consideration of recommendations made by the SAP, this reassessment will be guided by the findings of the 1999 National Academy of Sciences (NAS) report on Genetically Modified Pest-Protected Plants and the findings of the recently announced Administration-wide biotechnology review led jointly by the Council on Environmental Quality (CEQ) and the Office of Science and Technology Policy (OSTP). This CEQ/OSTP review is focused on the existing federal regulatory review structures to assess and regulate the environmental impacts of products of biotechnology. It is EPA's intention to extend the existing B.t. corn and cotton registrations until September 30, 2001. If not extended, these registrations will expire in April and January of 2001, respectively. EPA believes that in order to bring the results of all of the aforementioned activities to bear on our final assessment and renewal decisions, the additional time gained by extending the current registrations is necessary. EPA has strengthened resistance management requirements for both corn and cotton in the past year and believes these strengthened requirements, along with the original registration conditions, are more than adequate to be protective during the extension period. This notice sets forth the process that EPA intends to follow to reach regulatory decisions on the B.t. corn and B.t. cotton expiring registrations and extension of the existing B.t. product registrations. It also provides information on EPA's plans for Start Printed Page 48702finalizing core components of the Plant-Pesticides Rule, that was proposed on November 23, 1994.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

This action is directed to the public in general. This action may be of particular interest to manufacturers/producers, distributors, users, and other persons interested in the registrations listed below. This action may also be of interest to other persons who have an interest in the registration and/or the use of B.t. corn and B.t. cotton plant-pesticides regulated under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and under the Federal Food, Drug and Cosmetic Act (FFDCA). Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed in the FOR FURTHER INFORMATION CONTACT section.

B. Affected EPA Plant-Pesticides and Registrations

EPA plant-pesticides and registrations affected by the time extensions and reassessments are listed below.

Plant-Pesticide

EPA Registration

EPA Product Chemistry Code

Bacillus thuringiensis CryIA(b) Delta-endotoxin and the genetic material necessary for its production (Plasmid Vector pCIB4431) in corn

Novartis Seeds 66736-1 Mycogen Corp. 68467-1

006458

Bacillus thuringiensis CryIA(b) Delta-endotoxin and the genetic material necessary for its production (Plasmid Vector pZ01502) in corn

Novartis Seeds 67979-1 Novartis Seeds 65268-1

006444

Bacillus thuringiensis CryIA(b)
Delta-endotoxin and the genetic material necessary for its production in corn

Monsanto Crop. 524-489

006430

Bacillus thuringiensis subspecies tolworthi Cry9C protein and the genetic material necessary for its production in corn

Aventis 264-669

006466

Bacillus thuringiensis kurstaki
Delta-endotoxin as produced by the CryIA(c) gene and its controlling sequences as expressed in cotton

Monsanto Corp. 524-478

006445

C. How Can I Get Additional Information, Including Copies of this Document and Other Related Documents?

You may obtain electronic copies of this document, and certain other related documents (including copies of EPA's fact sheets on each registered B.t. plant-pesticide, workshop proceedings on resistance management, EPA technical papers on regulation of agricultural biotechnology including resistance management for B.t. plant-pesticides, ecological effects data requirements for protein plant-pesticides, allergenicity and health effects for protein plant-pesticides, and Scientific Advisory Panel reports from the EPA's Biopesticide Internet Home Page at http://www.epa.gov/​pesticides/​biopesticides and from the EPA's Scientific Advisory Panel Home Page at http://www.epa.gov/​scipoly/​sap). To access this document, on the Home Page select “Laws and Regulations” and then look up the entry for this document under the “Federal Register—Environmental Documents.” You can also go directly to the Federal Register listings at http://www.epa.gov/​fedrgstr/​.

D. Opportunities for Public Comment

The process that EPA will follow for the comprehensive reassessment of B.t. plant-pesticides is set forth below in Unit III.D. EPA encourages public comments for the Agency's consideration during the comprehensive reassessment of the existing B.t. corn and B.t. cotton registrations. Throughout the reassessment process, there will be opportunities for public comment.

II. Actions Being Taken and Authority

A. What Action is the Agency Taking?

EPA is announcing its process for conducting a comprehensive reassessment of the B.t. corn and B.t. cotton expiring registrations in order to reach regulatory decisions related to registration renewal. This process has been designed to allow for appropriate consideration of all relevant information and to assure a robust public participation process. EPA is announcing its intent to extend existing (B.t.) corn and cotton plant-pesticide registrations to remain in effect until September 30, 2001, providing time for the Agency to consider the recommendations of the SAP, the CEQ/OSTP Biotechnology review and public input. EPA is also announcing its plans for finalizing core components of the Plant-Pesticides Rule, that was proposed on November 23, 1994 (59 FR 60495) (FRL-4755-2).

B. What is the Agency's Authority for Taking This Action?

EPA's comprehensive reassessments of the expiring B.t. corn and cotton plant-pesticides will be conducted pursuant to its authority at section 3 of FIFRA. Extension of the period of registration for the expiring B.t. plant-pesticide registrations will be granted pursuant to section 3 of FIFRA. Start Printed Page 48703

III. Background and Explanation of Actions Being Taken

A. What is the History of B.t. Plant-Pesticide Registrations?

Prior to registering B.t. plant-pesticides and starting in the mid 1980's, EPA held a series of scientific and public meetings. Specifically, the Agency organized public meetings of the FIFRA Scientific Advisory Panel (SAP) and the Biotechnology Scientific Advisory Committee (BSAC) to consider technical issues related to biotechnology products that act as pesticides. The focus of these meetings was to discuss potential risks associated with this technology, and to identify the appropriate data requirements that would allow EPA to assess any risks associated with plant-pesticides. These collaborative efforts resulted in the development of a rigorous scientific review process and appropriate data requirements. Beginning in 1995, EPA has registered 11 plant-pesticide products. B.t. plant-pesticides are registered in corn, cotton, and potato. Two of the 11 original registrations have been or are in the process of being voluntarily canceled. Seven of the original 11 plant-pesticide registrations are for field corn, sweet corn, popcorn, and cotton. The remaining two existing registrations are for potatoes. These seven B.t. corn and cotton plant-pesticide registrations are time-limited registrations, currently scheduled to expire in April and January of 2001, respectively. Data required by EPA includes characterization of the active ingredient (to date, all pesticidal substances have been proteins) and the genetic material including promoters, etc. used to make the pesticidal substance in the plant, information on the donor organism and the host plant, and extensive data on the protein itself. In addition, studies are required on toxicity to mammals, non-target organisms and beneficial species, and the fate of the substance in the environment.

EPA has continued to hold SAP meetings to periodically reevaluate the data requirements applied to plant-pesticides to ensure that all appropriate health and safety aspects are covered in light of any new data. Development of insect resistance to B.t. microbial pesticide products from the wide-spread use of B.t. crops was one of the major concerns that was expressed in these early and subsequent public meetings. In registering B.t. plant-pesticides, EPA has taken extensive and unprecedented measures to significantly reduce the likelihood that insects exposed to B.t. plant-pesticides will develop resistance. Well before registration of the first B.t. plant-pesticide in 1995, EPA engaged in consultations regarding resistance management for B.t. plant-pesticides with the U.S. Department of Agriculture (USDA), potential registrants, academics, farmers, and public interest groups. In addition, potential registration applicants had been conducting or sponsoring research on the biology and ecology of the insect pests, biology of resistance, and many other aspects of effective resistance management. As a condition of the registrations, EPA required that all applicants for B.t. plant-pesticide registrations provide EPA with insect resistance management (IRM) plans, including monitoring and submission of monitoring data. Subsequent to the registration of the first B.t. crops in 1995, substantial information has been developed that has enhanced EPA's understanding of the requirements of IRM plans. Since 1995, EPA has modified the structured refuge requirements for B.t. crops as indicated by the evolving science. Moreover, EPA has mandated certain risk mitigation measures to ensure that selection pressure is effectively managed and the risk of insect resistance development to B.t. plant-pesticides is minimized. The Agency has required or recommended generation of specific research data, development and implementation of structured refuges, annual resistance monitoring, remedial action plans, grower education, and sales and research reporting for certain B.t. crops as part of the development and implementation of long-term IRM strategies.

EPA is working closely with academia, other federal agencies, public interest groups, industry, and growers to continue to refine and implement effective insect resistance plans, based on the most current science, that provide consistency, effectiveness, and flexibility.

B. What is EPA's Approach to Plant-Pesticides?

EPA has been and remains fully committed to assuring that the review, assessment and registration of biotechnology products meet the stringent standards required by FIFRA and the FFDCA, and are fully protective of public health and the environment. Prior to the 2000 growing season, EPA worked with U.S. farmers and the manufacturers of B.t. corn products, via the Agricultural Biotechnology Stewardship Working group, to put strengthened resistance management plans in place. This collaborative effort was undertaken in response to the availability of new information regarding insect resistance and potential non-target species impacts. EPA has worked similarly with the B.t. cotton registrant and cotton growers to put strengthened resistance management plans in place for the 2001 growing season.

It is EPA's goal to assure that we continue to make our regulatory process and decisions within a sound and transparent process framework and that we are fully informed by the most recent and scientifically sound information. The Agency will assure a transparent and interactive review process for its decisions and will make every effort to involve all of our stakeholders—the manufacturers, the growers, and the public—to provide the public with confidence in EPA's regulatory decisions and provide U.S. farmers with the tools they need to continue to produce a safe and healthy food supply.

C. What is the Rationale for the Action the Agency is Taking?

EPA is conducting a comprehensive reassessment of expiring B.t. corn and cotton plant-pesticide registrations, including pest management resistance requirements, to ensure public health and environmental protection. This process will be scientifically based and provide increased opportunities for public comment and participation on both EPA's comprehensive risk assessment and risk management proposals. EPA intends to extend the existing B.t. corn and cotton plant-pesticide registrations to remain in effect until September 30, 2001. Absent extension, these registrations will expire in April and January of 2001, respectively. EPA will extend these registrations to ensure that the comprehensive reassessment can be completed and subsequent regulatory decisions made, prior to expiration of the B.t. corn and cotton registrations. EPA believes that such extensions are appropriate and necessary to ensure that farmers are provided with adequate time to evaluate their options for the 2002 growing season. EPA plans to complete risk assessment recommendations in the late spring or early summer of 2001. Without the extensions, farmers will have inadequate information to make their seed buying decisions for the 2002 growing season. The Agency also believes that such extensions are necessary to assure that there is no confusion regarding the legal status of these plant-pesticide products during their normal use period. Moreover, by extending these registrations, EPA may more fully engage the public in the comprehensive reassessment in a Start Printed Page 48704manner that will ensure that adequate time and data are available to support a thorough reassessment of original data; ensure that newly submitted ecological data are factored into the assessment; provide ample time for scientific peer review of EPA's assessment by the SAP; provide ample time for public review and comment; allow consideration of recommendations coming from the recent NAS study of genetically-modified pest-protected plants and the recently announced Administration-wide review of the adequacy of existing regulatory structures to assess and regulate potential environmental impacts of biotechnology products. Pursuant to its statutory obligations under FIFRA, EPA has determined that the extension of these registrations will not cause unreasonable adverse effects on the environment.

D. What Future Actions Will the Agency be Taking?

EPA worked with U. S. farmers and the manufacturers of B.t. corn products to put in place strengthened insect resistance management plans for the 2000 growing season. The Agency believes these strengthened measures are necessary and will continue for the 2001 growing season. EPA has also worked with farmers and the B.t. cotton registrant. The B.t. cotton product has been recently amended to increase both the size and proximity requirements of the required refuge, along with strengthening the educational program for users. These measures provide for increased protection from the potential onset of resistance. In addition, the Agency reserves the right to ensure that any additional potential protections are implemented for the 2001 season if additional information is received that would warrant such action.

Over the coming months, EPA will be developing a comprehensive updated risk assessment that will be used to assess whether existing B.t. plant-pesticide registrations should be renewed, and if renewals are appropriate whether they should be with or without modification. That assessment will include not only data and information that was reviewed for the original assessments, but will also incorporate new data, including recently submitted monarch butterfly data, guidance from SAP meetings, recommendations from the National Academy of Sciences and the CEQ/OSTP biotechnology review, and all public comments. The NAS report focused on investigating the risks and benefits of genetically modified pest-protected plants and the coordinated federal framework for regulation of biotechnology. The Administration-wide review is a more focused effort, assessing the present regulatory framework for all federal agencies involved with biotechnology. This inter-agency review calls for the creation of case studies that reflect the regulatory processes of each of the federal agencies involved in the registration and sale and distribution of B.t. plant-pesticides and other biotechnology products and will be used to examine and possibly make recommendations to strengthen existing regulatory structures.

EPA expects to complete that preliminary assessment by late summer and have a rigorous public review of the assessment. EPA will include in this process an opportunity for the manufacturers to provide EPA with technical corrections to the preliminary risk assessment. The registrants error correction comments and corrective actions taken by the Agency will be placed in the docket established for B.t. crops. After any corrections have been made, EPA will invite public comment on the risk assessment through the Federal Register and the EPA website. At that time the Agency will also announce a date and place for an SAP meeting. All public comments received before the SAP meeting will be given to the SAP for their consideration. The public is encouraged to provide comments at the SAP meeting. The reassessment process has been designed to assure maximum transparency of the decision making process and the data and information that underlie final Agency decisions, and to assure that all stakeholders have ample time for review and participation in the process.

EPA's final assessment, renewal decisions and risk mitigation plans will be completed after careful consideration of all comments and after any recommendations coming from the Administration-wide review have been evaluated. EPA intends to provide appropriate opportunities for public input on the risk management plans before final decisions are announced.

It is EPA's goal to adhere to a transparent and interactive review process. The Agency is committed to working with all stakeholders to provide the public with confidence in EPA's regulatory decisions and provides U.S. farmers with the tools they need to continue to produce a safe and healthy food supply.

E. What are the Process and Schedule for EPA's Reassessment of Existing B.t. Corn and B.t. Cotton Plant-Pesticides?

It is EPA's goal to provide for an open and transparent public process that incorporates sound and current science, public involvement, and balanced decision making. As currently envisioned, the major components of this process and time frames for action are as follows:

1. Comprehensive risk assessments. EPA is currently in the process of evaluating its scientific risk assessments for B.t. products. This review will incorporate all available scientific information on B.t. products, including results of recent scientific studies and recommendations from various individuals and organizations. (Summer/Fall 2000)

2. Scientific Peer Review and public comment. After completing our scientific risk assessment, the Agency will provide the registrants of the products an opportunity to review the risk assessment and suggest technical corrections to the Agency. After any corrections are made, EPA will release the risk assessments and invite public comment and scientific peer review. That release will include EPA's regulatory assessment and the underlying data, along with any registrants error correction comments and the corrective actions taken by the Agency. All of these materials will be placed in the docket established for B.t. crops. (Fall 2000)

3. Recommendations from the Scientific Advisory Panel, National Academy of Sciences, public comments, and the Administration-wide review. Since there are many organizations providing regulatory and scientific recommendations to EPA, this period will be used to consider and incorporate as appropriate recommendations into our revised risk assessment. This will include recommendations from the Scientific Advisory Panel on insect resistance management, ecological and public health aspects of our regulatory program, along with consideration of issues identified in the report released by the National Academy of Sciences titled: “Genetically Modified Pest-Protected Plants, Science and Regulation” and the Administration-wide review. Any available recommendation from the Administration-wide review will also be addressed at this time. (Fall 2000, Winter 2000/1)

4. Revised risk assessments and propose registration requirements. After incorporating the appropriate recommendations, the Agency will Start Printed Page 48705revise its risk assessments, and develop registration decision documents for future growing seasons. This will include any strengthening measures for issues including insect resistance management, the protection of non-target organisms, and other measures necessary to ensure full public and environmental safety. The Agency will ask for public comment on the revised risk assessment and any proposed regulatory actions. (Winter 2000/1 to Early Spring 2001)

5. Final decisions onB.t. registrations. This will complete the scientific and public process with EPA providing decisions on the B.t. registrations for the 2002 growing season. At this time, EPA will announce final regulatory conclusions regarding these registrations. (Late Spring to Summer 2001)

IV. Status of Plant-Pesticide Rule

In concert with the Agency's commitment to keeping interested parties informed, EPA is taking this opportunity to provide an update on the plant-pesticide rules proposed on November 23, 1994 (59 FR 60495). While EPA continues to believe that specific registration decisions can be made while the generic process is being developed, EPA is using this notice as a vehicle for providing information on the generic rules because many readers of this notice are also interested in EPA's other plant-pesticide plans.

EPA plans to publish a final rule later this year establishing the core components of the Agency's oversight of certain plant-pesticides under FIFRA. This final rule would amend EPA's regulations at 40 CFR 152.20 pertaining to oversight of biological control agents. Generally, this rule will clarify how EPA will regulate genetically engineered plant-pesticides while exempting traditional plant breeding from EPA oversight under FIFRA and FFDCA.

EPA also plans in that notice to solicit public comment on the recommendations in the National Academy of Sciences report titled “Genetically Modified Pest-Protected Plants: Science and Regulation” as they relate to the parts of the rule that will not be made final. In its report, the NAS recommended that EPA reconsider its proposed exemptions for: modifications to sexually-compatible plants accomplished using rDNA techniques; viral coat proteins, and plant pesticides that act primarily through non-toxic modes of action (e.g., by affecting the physical properties of plants).